Tilburg double blind randomised controlled trial comparing inguinal hernia correction with anterior approach via Lichtenstein or Polysoft.

Tilburg double blind randomised controlled trial comparing inguinal hernia correction with anterior approach via Lichtenstein or Polysoft. - The Tulip trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31037

Enrollment

300

Registered

2007-10-15

Start date

2008-10-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hernia ventralis inguinal hernia

Interventions

One group will be operated via an anterior approach with mesh placement according to Lichtenstein, the other group will be operated via an anterior approach with Polysoft® mesh placement in the prep

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Primary groin hernia unilaterally, Age > 18 years. ASA classification 1-3, Signed informed consent letter

Exclusion criteria

Exclusion criteria: Recurrent hernia, Age 80, Scrotal hernia*s , ASA 4/5, Acute incarcerated inguinal hernias, Psychiatric disease or other reason making follow up of filling in questionnaires unreliable.

Design outcomes

Secondary

Measure	Time frame
Secondary endpoints are length of operation, postoperative complications, length of hospital stay, return to daily activities and work, costefficiency analysis, health related quality of life and recurrence.	—

Primary

Measure	Time frame
Primary endpoint will be difference in pain and chronic pain postoperatively.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)